Safecor Health, LLC recalls Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and o…

Recall date

August 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0657-2016

FDA classification

Class II

Brand / firm

Safecor Health, LLC

Sold / distributed

NY

Why it was recalled

Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.